This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.
Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe agitation secondary to AD. This is a multicenter, randomized, double-blind, placebo-controlled, parallel-design study, consisting of 12 weeks of treatment. Approximately 550 participants will be enrolled at approximately 90 centers worldwide. Study medication will be administered orally twice-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
601
Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score
Time frame: Baseline; Week 12
Change from Baseline to Week 12 in the Clinical Global Impression of Severity (CGIS)-Agitation Domain Score
Time frame: Baseline; Week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
MD First Research #767
Chandler, Arizona, United States
Liv Generations of Agritopia / CCT #573
Gilbert, Arizona, United States
Liv Generations of Ahwatukee / CCT #784
Phoenix, Arizona, United States
Perseverance Research Center
Scottsdale, Arizona, United States
Medical Advancement Center of Arizona #820
Tempe, Arizona, United States
Clinical Trials Inc.
Little Rock, Arkansas, United States
Advanced Research Center, Inc #835
Anaheim, California, United States
ATP Clinical Research, Inc #763
Costa Mesa, California, United States
Paradigm Clinical Research Centers, Inc.
La Mesa, California, United States
Sunwise Clinical Research #831
Lafayette, California, United States
...and 201 more locations